Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
13684 participants
OBSERVATIONAL
2021-10-01
2025-05-31
Brief Summary
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Detailed Description
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Some drugs, including beta blockers and amiodarone may help prevent AF if given after surgery. However, these may also lead to complications (such as lung damage). It is therefore important to identify which patients are most likely to benefit from these treatments (i.e., where the benefits outweigh the risks). There are existing tools designed to predict the risk of suffering AF after heart surgery. However, they are unreliable and therefore not used in clinical practice. A modern, reliable risk prediction tool is needed.
The PARADISE study will develop and test new prediction tools to identify which patients are most at risk of developing AF after heart surgery. The investigators will focus our tools on those patients who most commonly develop AF, such as those who have had surgery to repair a valve or blood vessel in their heart.
To do this the investigators will:
* Review the medical literature and assemble a panel of medical experts to create a list of known factors that affect patients' risk of AF after heart surgery
* Use a large UK general practice database (CALIBER) to see whether the investigators can find new risk factors.
* Ask the expert panel to agree a list of known and new risks factors to be included in the prediction tool.
* Develop two new prediction tools using an existing American cardiac surgery database (the Partners research Database). The first will be used before surgery, the second immediately following surgery. Two models are needed as events during surgery may alter the risk of AF.
* Test how reliably our new tools predict which patients suffer AF after surgery, with data from large UK (United Kingdom) NHS (National Health Service) heart centres, one US Hospital (Brigham) and a UK clinical trial (Tight-K).
* The investigators will work with two charities (AF Alliance and StopAfib) to share our results with patients and the wider public.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Retrospective
Patients admitted to Mass Brigham Hospitals for cardiac surgery from 1st January 1998 to 31st December 2020
Not applicable as observational study
Not applicable as observational study
Prospective
Patients admitted to Barts Health, Liverpool Heart and Chest Hospital, or Oxford University Hospitals NHS Foundation Trust for cardiac surgery between 1st October 2021 to 31st July 2023
Not applicable as observational study
Not applicable as observational study
Interventions
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Not applicable as observational study
Not applicable as observational study
Eligibility Criteria
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Inclusion Criteria
* Admitted to hospital for any cardiac surgery
Exclusion Criteria
18 Years
ALL
No
Sponsors
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St. Bartholomew's Hospital
OTHER
University College, London
OTHER
Liverpool Heart and Chest Hospital NHS Foundation Trust
OTHER
Brigham and Women's Hospital
OTHER
Oxford University Hospitals NHS Trust
OTHER
University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Peter Watkinson, MD
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Benjamin O'Brien, MD
Role: PRINCIPAL_INVESTIGATOR
Deutsches Herzzentrum der Charité
Locations
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Critical Care Research Group, Nuffield Department of Clinical Neurosciences, University of Oxford
Oxford, Oxfordshire, United Kingdom
Countries
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References
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Bedford J, Fields KG, Collins GS, Lip GYH, Clifton DA, O'Brien B, Muehlschlegel JD, Watkinson PJ, Redfern OC. Atrial fibrillation after cardiac surgery: identifying candidate predictors through a Delphi process. BMJ Open. 2024 Sep 25;14(9):e086589. doi: 10.1136/bmjopen-2024-086589.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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PID15669
Identifier Type: -
Identifier Source: org_study_id
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